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The Home Care Bead Bed is designed to provide Air Fluidized Therapy that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers, while providing minimized dehydration.

The Head Cushion System is an air inflatable cushion system designed to raise a patient's upper body. This cushion system is a replacement to the foam cushion wedges presently available on the FluidAir Bead Bed.

The Home Care Bead Bed is indicated for patients who would benefit from advanced pressure relief and a dry patient environment. Particular classes of such patients include (among others), victims of the following:

• Pressure Ulcers especially draining wounds .
• . Skin Flaps and Grafts
• · Burns
• · Acute Exfoliative Dermatitis
• · Oncology:
  • · Aids in pain relief
  • · Reduces risk of Pathological Fractures

The Home Care Bead Bed is designed to provide Air Fluidized Therapy by supporting the patient on a surface of fluidized Microspheres (or "beads"). A large volume of air is forced upward through the microsphere mass causing the beads to behave as a fluid, helping reduce interface pressures while providing a dry patient environment with minimized dehydration. The Home Bead Bed is designed for home health care use allowing easy two-man transportation, installation and serviceability. The Home Bead Bed is a modification of the predicate fluidized bead bed, FluidAir® (by KCI), currently on the market and complies with the weight regulations for mobile and wood floor homes.

The Home Care Bead Bed is comprised of the Head Pedestal (containing the Head Cushion System Control unit), the Foot Pedestal (containing the Power-Controller unit), the Tank unit with the Soft Diffuser, a wooden Floor Board, the Beads, Filter Sheet and the Head Cushion System incorporated into the Cover Sheet.

The Foot Pedestal encloses the Air Supply unit that provides air to the soft diffuser and the Head Cushion System. The Air Supply unit contains similar components used in the FluidAir power unit such as blowers, heat exchanger, thermostat controls, cooling fans and filters. The Power-Control Unit located at the Foot Pedestal (refer to membrane diagram) has an "On/OFF" button and a "Fluidization" knob that allows the care giver to increase or decrease the fluidization. By turning the knob toward "MAX", the blower speed increases and sends more air through the Soft Diffuser thus increasing the fluidization rate. By turning the knob toward "MIN", the blower speed decreases and less air is blown through the diffuser thus decreasing the fluidization rate. The "Temp" knob on the Power-Control Unit allows the care giver to adjust the temperature of the air flowing to the beads. This heating and cooling regulation system is similar to the one used on the FluidAir.

The Head Cushion System consists of a head cushion (consisting of two air bladders) and a knee gatch bladder made of vinyl Gore-Tex® fabric and sewn onto a Gore-Tex® fabric cover sheet, similar to the FluidAir bed cover sheet, and placed atop the Home Care Bead bed. The two head cushion bladders and the knee gatch bladder are controlled by small bore servo valves located in the Head Pedestal. These valves are connected to individual port pins for appropriate control. The top head cushion bladder is operated in a pressure feedback mode, while the bottom head cushion operates only in an ON or OFF mode (no pressure feedback control). The knee gatch valve is plumbed in such a way as to draw air from the bottom head cushion bladder whenever the "High" setting is selected. Otherwise, the knee gatch bladder remains deflated. Forty (40) degrees of elevation can be achieved when both head cushions are inflated. The knee gatch bladder provides greater patient positioning when the bottom head cushion is elevated.

The Hand Control has an ON and OFF control for fluidization, and SOFT and FIRM and HIGH and LOW controls for the Head Cushion System. When the Head Cushion System's power is turned ON, the system defaults to the LOW setting of mid-range firmness for the Top Head cushion. The Bottom Head cushion and Knee Gatch cushion remain deflated. The FIRM and SOFT control buttons adjusts the firmness level of the Top cushion. The HIGH control button fully inflates the Bottom Head cushion and the Knee Gatch bladder. The head will elevate to a maximum of 40 degrees, depending on the firmness of the Top Head Cushion. The LOW control button returns the Low setting, which will return the head elevation to approximately 10 degrees. When the Head Cushion System is turned OFF, all cushions in the Head Cushion System are deflated.

This document is a 510(k) summary for the "Home Care Bead Bed" and describes its intended use, indications, and contraindications. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document states that the Home Care Bead Bed is a modification of a previously marketed device, the FluidAir® (K881917), and is considered "substantially equivalent." The FDA clearance (K972176) is based on this substantial equivalence, not on a new study demonstrating performance against specific acceptance criteria for the modified device.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results.

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The CLINITRON® RITE®HITE™ Air Fluidized Therapy is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in circulation. This bed will be an ideal support for patients who have advanced pressure ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation and any other conditions appropriate for air-fluidized therapy. The bed also can be used for intractable pain, extensive epidermal detachment, Stevens-Johnson Syndrome, purpura fulminans, aid in infection control, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time. The bed will permit easy positioning and egress, thereby enhancing the independence of residents.

The CLINITRON® RITE®HITE™ Air Fluidized Therapy Unit combines the best features of the predicate devices, CLINITRON ELEXIS® (K943385)and the CLINITRON AT+HOME® (K942184), in order to meet the design objectives. The intent of the design is to provide an economical combinational therapeutic support surface on a mobile articulating frame specifically for use in the Long Term Care setting. Another design objective was to provide this type of surface on a frame that would go as low as possible. The CLINITRON® RITE®HITE™ tank edge is at 21.5 inches in its lowest position. This will permit easier positioning and egress. The combinational support surface includes both low airloss and air fluidized therapies. The upper half delivers low air loss therapy through low-friction support cushions which supports the upper half of the body (above the waist) and the lower half consists of air fluidized therapy which supports the lower half of the body (below the waist). This type of sleep surface is common to both the CLINITRON ELEXIS and the CLINITRON AT.HOME®

The provided text describes a 510(k) premarket notification for the CLINITRON® RITE•HITE™ Air Fluidized Therapy unit. The core of this submission is to demonstrate substantial equivalence to predicate devices, rather than establishing new safety and efficacy through a detailed clinical study with acceptance criteria and a detailed study design as typically seen for novel devices.

Therefore, the document does not provide the specific information requested about acceptance criteria, a standalone study to prove performance against those criteria, sample sizes, expert qualifications, or adjudication methods for a novel device. Instead, it focuses on comparing the new device's features and intended use to existing, legally marketed devices.

Here's how the provided information relates to your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo clearance requiring novel performance criteria. The "acceptance criteria" are effectively that the device is "substantially equivalent" in safety and efficacy to the predicate devices.
• Reported Device Performance: The document states, "The safety characteristics of this product compare to those of the predicate devices. No significant changes have been made which impact the safety and efficacy of the CLINITRON® RITE. HITE™ Air Fluidized Therapy Unit as compared to the predicate devices." No specific quantitative performance metrics are provided beyond this qualitative statement.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: No "test set" in the context of a performance study is described. The demonstration of substantial equivalence relies on comparative analysis with predicate devices, not on a new clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: No "test set" requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: No "test set" requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is an air-fluidized therapy unit, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader improvement with AI is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable: No "ground truth" data from a performance study is mentioned. The "truth" in this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable: As above, no training set is relevant here.

Summary of Device and Evidence for Substantial Equivalence:

The CLINITRON® RITE•HITE™ Air Fluidized Therapy unit is intended for medical purposes to treat or prevent bedsores, severe burns, or to aid circulation. It combines features of two predicate devices: CLINITRON ELEXIS® (K943385) and CLINITRON AT•HOME® (K942184).

Key arguments for substantial equivalence (which serve as the "proof" the device meets the regulatory requirements for market clearance):

• Intended Use: The CLINITRON® RITE•HITE™ has the same intended uses as the predicate devices: providing a pressure-relieving sleep surface for patients with pressure ulcers, burns, flaps, grafts, and other conditions suitable for air-fluidized therapy.
• Technological Characteristics:
  • Uses the same air fluidization medium (silicon-coated glass microspheres).
  • Employs the same principle of passing pressurized air through a diffuser board to fluidize microspheres and through a filter sheet to the patient.
  • Uses the same microspheres, filter sheet fabric, and similar closure systems.
  • Incorporates similar cushion sections for pressure relief and articulable head sections.
  • Has air cushions organized into zones continuously monitored by a microprocessor to adjust pressures.
  • Uses identical cushion material and construction to predicate devices.
  • Operated and controlled by a microprocessor.
• Safety and Efficacy: The submission explicitly states: "The safety characteristics of this product compare to those of the predicate devices. No significant changes have been made which impact the safety and efficacy of the CLINITRON® RITE. HITE™ Air Fluidized Therapy Unit as compared to the predicate devices."
• Differences and Justification: While there are differences (e.g., design for long-term care vs. acute care, specific features like CPR function, X-ray plates, built-in scales, remote control design, siderail mechanisms, specific alarm behaviors), the manufacturer argues that "Although these differences provide servicing and user benefits, none of the differences adversely affects the safety or efficacy of the device."

In conclusion, this 510(k) submission successfully demonstrated substantial equivalence by highlighting the similarities in intended use and technological characteristics to already-approved predicate devices, and by arguing that differences did not compromise safety or efficacy. It did not involve performance testing against specific acceptance criteria in the manner of a clinical trial for a novel device.

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